Zelboraf

Zelboraf

vemurafenib

Manufacturer:

Roche

Distributor:

Firma Chun Cheong
/
DKSH
Concise Prescribing Info
Contents
Vemurafenib
Indications/Uses
Monotherapy for treatment of adults w/ BRAF V600 mutation-positive unresectable or metastatic melanoma.
Dosage/Direction for Use
960 mg (4 tab of 240 mg) bd. Total daily dose 1920 mg.
Administration
May be taken with or without food: Swallow whole, do not chew/crush.
Contraindications
Special Precautions
Wild type BRAF malignant melanoma. Discontinue in cases of severe hypersensitivity & dermatologic reactions. QT prolongation. Ophthalmological reactions. Cutaneous & non-cutaneous squamous cell carcinoma. New primary melanoma. Prior or concurrent cancer associated w/ RAS mutation. Monitor liver enzymes & bilirubin prior to or during therapy, & as clinically indicated. Renal & hepatic impairment. Mild to severe photosensitivity. May affect ability to drive or operate machinery. Pregnancy & lactation. Non-Caucasian. Childn.
Adverse Reactions
Cutaneous squamous cell carcinoma. Arthralgia, fatigue, rash, photosensitivity reaction, nausea, alopecia, pruritus.
Drug Interactions
Increased & decreased plasma exposure of medicines metabolized by CYP1A2 & CYP3A4, respectively. INR monitoring concomitant w/ warfarin. P-gp & CYP3A4 inducers & inhibitors. Ipilimumab. Bupropion. A washout period of 8 days is necessary to avoid interaction w/ subsequent treatment.
ATC Classification
L01XE15 - vemurafenib ; Belongs to the class of protein kinase inhibitors, other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Zelboraf FC tab 240 mg
Packing/Price
56's
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